MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number QC-7-30-3D |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received a report that the qc-7-30-3d coil was automatically detached, and part of the coil was in the blood vessel.Then a qc-3-8-3d was used for filling.During the filling process, it was found the coil was automatically detached.The pushwire was pulled out, and part of the coil was in the vascular cavity.One sab-6-30 was implanted to press the two coils against the side wall of the vessel.There was no damage to the pushwires, no resistance experienced during deliver, no detachment attempts made, no repositioning or rotation of the pushwire, and a continuous flush had been administered during the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the right posterior communicating (pcom) artery c7 with a max diameter of 7.5 mm and a 4 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.Refer to manufacturer report 2029214-2021-00553 for details pertaining to the related reportable event.
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Event Description
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Additional information received reported that the coils and solitaire ab remain in the right a1 and a2 blood vessels.There were no problems with the qc-7-30-3d pushwire.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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